Update on the Regulation of LDTs: FDA, VALID Act, CLIA Modernization, and More
(6)
Sponsored by the ACMG Advocacy and Government Affairs Committee
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Availability
Retired
Cost
$0.00
Credit Offered
No Credit Offered

Join us for Part One of our captivating webinar series: "Translating Genes into Health®".

 

📅 May 21, 2024

2:00 pm – 3:00 pm ET

  

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Update on the Regulation of LDTs: FDA, VALID Act, CLIA Modernization, and More

Sponsored by the ACMG Advocacy and Government Affairs Committee

May 21, 2024 | 2:00 – 3:00 pm ET

 

Educational Credits are not offered.

Description:

Join members of ACMG’s Advocacy and Government Affairs Committee and Policy Team to hear updates on potential changes to the regulation of laboratory-developed tests (LDTs) in the US. Speakers will provide updates on the current status of the FDA’s final rule on regulation of LDTs and its implementation. They will also provide updates on congressional involvement, including legislative efforts such as the VALID Act and CLIA Modernization.

 

Target Audience

All healthcare professionals.

 

Agenda

Michelle McClure, PhD – Intro & FDA update (15 minutes)

Marco Leung, PhD, FACMG – VALID Act (15 Minutes)

Sarah South, PhD, FACMG – CLIA Modernization (15 minutes)

Q&A (15 minutes)

Learning Objectives

At the conclusion of this session, participants should be able to:

  1. Summarize the current regulatory and legislative landscape of proposed policies that would change how LDTs are regulated.
  2. Assess the impact of the FDA rule on LDT regulation on clinical testing laboratories.
  3. Explore the remaining opportunities to block or overturn the FDA proposed rule on LDTs.

 

A person standing in front of a flagDescription automatically generated

Michelle McClure, PhD

 ACMG Director of Public Policy

 

A person in a cardigan and plaid shirtDescription automatically generated

Marco Leung, PhD, FACMG

Advocacy & Government Affair Committee Chair

 

Sarah South

Sarah South, PhD, FACMG

ACMG Board of Directors

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